(62 days)
The Unimax Trocar System, Model: Auto-Locking Trocar, Bladeless Trocar, Visible Trocar, Hasson Trocar, Dilating Trocar, Secondary Trocar, and Thoracic Trocar has application in a variety of endoscopic procedures to provide a port of entry for endoscopic instruments.
The Auto-locking Trocar has application in a variety of endoscopic procedures to provide a port of entry for endoscopic instruments. The Auto-locking Trocar is available from 3-15mm. The cannula assembly has a universal seal, a valve, and a stopcock. This device has a bladed tip with an internal shield, which is designed to cover the cutting edges once the body cavity has been entered. The cannula assembly has universal seal and stopcock.
The Bladeless Trocar has application in a variety of endoscopic procedures to provide a port of entry for endoscopic instruments. The Bladeless Trocar is available from 3-15mm The cannula assembly (10mm and 12mm type) has a universal seal, a valve, and a stpcock. The cannula assembly (5mm type) has a stopcock.
The Visible Trocar has application in a variety of endoscopic procedures to provide a port of entry for endoscopic instruments. The Visible Trocar is available from 5-15mm. Visible Trocar allows direct visualization of the abdominal wall layers when the trocar is traversed, which offers a safe and rapid option of primary trocar. The cannula assembly has a universal seal, a valve, and a stopcock.
The Hasson Trocar has application in a variety of endoscopic procedures to provide a port of entry for endoscopic instruments. The Hasson Trocar is available from 3-15mm. This device has a blunt tip, which is designed for open Laparoscopy. The cannula assembly has a fixation device, a universal seal, a valve, and a stopcock.
The Dilating Trocar has application in a variety of endoscopic procedures to provide a port of entry for endoacopic instruments. The Dilating Trocar is available from 3-15mm. This device has a non-bladed conical tip which offers enhanced security to enter the abdomen. The cannula assembly has two-ply of seal and stopcock. There is a built-in universal seal.
The Secondary Trocar has application in a variety of endoscopic procedures to provide a port of entry for endoscopic instruments. The Secondary Trocar is available in 2 different lengths: 5mm/7cm and 5mm/10cm. This device has a non-bladed conical tip which offers enhanced security to enter the abdomen. The cannula assembly has two-ply of seal and stopcock.
The Thoracic Trocar consists of a blunt-tipped obturator and a threaded cannula. It is designed for instrument stabilization and also protect against foreign materials entering the chest cavity. Once inserted into the chest, the Thoracic Trocar must be turned clockwise until it is securely seated in the tissue. There are four types of Thoracic Trocars: 6mm/7cm, 11mm/7cm, 13mm/7cm, and 15mm/7cm.
The Unimax Trocar System's acceptance criteria and the study proving it meets these criteria are described below:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Performed | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Obturator Compatibility | Device functions as intended, allowing obturator and cannula to interface correctly without issues. | Meets requirements. |
| Insertion & Cannula Stability | Device can be inserted stably and the cannula remains stable without dislodgement or excessive movement. | Meets requirements. |
| Air Leakage | Minimal to no air leakage through the device to maintain pneumoperitoneum. | Meets requirements. |
| Biocompatibility (ISO 10993-1, 5, 10, 12) | No adverse biological reactions upon contact with tissues; appropriate for medical device use. | Meets requirements. |
| Sterilization (ISO 11135-1) | Device can be effectively sterilized by Ethylene Oxide (EO) to achieve sterility assurance level. | Meets requirements. |
| Safety Testing | No safety concerns raised during testing. | Meets requirements. |
2. Sample Size and Data Provenance for Test Set
The document does not specify the exact sample sizes used for each performance test (Obturator Compatibility, Insertion & Cannula Stability, Air Leakage). The data provenance is also not explicitly stated in terms of country of origin or whether it was retrospective or prospective, although it can be inferred that the testing was conducted by or for Unimax Medical Systems Inc., a company located in Taiwan. These were non-clinical bench tests performed on the device itself.
3. Number and Qualifications of Experts for Ground Truth
This information is not applicable. The Unimax Trocar System is a physical medical device, and the "ground truth" for its performance is established through objective engineering and safety tests rather than expert interpretation of medical images or clinical outcomes that would require expert consensus.
4. Adjudication Method for Test Set
This information is not applicable for a physical device undergoing performance and safety bench testing. Adjudication methods like 2+1 or 3+1 are used in studies involving subjective interpretations (e.g., medical image analysis) to resolve discrepancies among multiple expert readers.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done. This type of study is relevant for diagnostic devices or AI-assisted systems where human reader performance is being evaluated with and without AI assistance. The Unimax Trocar System is a surgical instrument.
6. Standalone Performance Study
Yes, a standalone performance study was done for the device. The document explicitly states: "A series of safety tests were performed to assess the safety and effectiveness of the Unimax Trocar System." And "The performance testing conducted on subject device and predicate device are listed below: Obturator Compatibility, Insertion & Cannula Stability, Air Leakage." The conclusion states, "After analyzing bench tests, safety testing data, it can be concluded that: Unimax Trocar System is as safe and effective as the predicate device."
7. Type of Ground Truth Used
The ground truth for the performance of the Unimax Trocar System was established through objective measurements and observation during non-clinical bench testing for physical characteristics (e.g., fit, stability, leakage) and through adherence to recognized international standards for biocompatibility (ISO 10993 series) and sterilization (ISO 11135-1).
8. Sample Size for Training Set
This information is not applicable. The Unimax Trocar System is a physical medical device, not an AI or machine learning algorithm that requires a training set.
9. How Ground Truth for Training Set was Established
This information is not applicable as there is no training set for this device.
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.